The current clinical efficacy evaluation system and evaluation methods of acupuncture have several limitations, and the application status is not optimistic. According to long-term observation, minimum clinically important difference (MCID) is consistent with the characteristics of clinical acupuncture, and has objective quanti- tative standard and wide applicability. Incorporating MCID into acupuncture clinical efficacy evaluation of tradition- al Chinese medicine can truly reflect the clinical effect of acupuncture and improve the disadvantages and shortcom- ings of acupuncture clinical evaluation, which could provide certain reference for building clinical efficacy evaluation system featured with TCM.
Acupuncture Therapy ; standards ; Clinical Trials as Topic ; standards ; Humans ; Moxibustion ; standards

Clinical Trials as Topic ; standards ; Humans ; Quality Control

A CDASH-based CRF annotation plays an important role in database setup and data verification. The STDM-based CRF annotation is also one of the essential documents when the package of clinical trial data is submitted to the regulatory authority. This paper describes the contents, procedures and related stipulations used in the CDISC-based CRF annotation.
Clinical Trials as Topic ; Databases, Factual ; Documentation ; standards

Based on detailed explanation of the herbal CONSORT statement, and the consideration of the character of traditional Chinese drugs, to discuss the standardization of reporting traditional Chinese drug trials. The standards of reporting traditional Chinese drug trials are not consolidated yet. In the year 2006, Reporting Randomized, Controlled Trials of Herbal Interventions: An Elaborated CONSORT Statement was developed by the CONSORT group and published. This herbal CONSORT statement includes 5 parts, and totally 22 items, in which the items of participant criteria, intervention, control setting and outcomes, et al. are elaborated to be adaptable to herbal intervention trials. This herbal CONSORT statement has provided valuable basis for the development of standards of reporting traditional Chinese drug trials, though it is not completely adaptive to be the reporting standards in consideration of the background theory and the animal drugs and mineral drugs that traditional Chinese drugs contain. The proper reporting standards of traditional Chinese drug trials should take the different types of drugs and the different purposes of trials into consideration. The trial reports of drugs that must be applied under the instruction of traditional Chinese medicine (TCM) theory should report participant criteria that include TCM syndrome differentiation and other important characters of TCM interventions.
Clinical Trials as Topic ; standards ; Medicine, Chinese Traditional ; standards ; Publishing ; standards ; Randomized Controlled Trials as Topic ; standards

According to Standard Protocol Items: Recommendations for Interventional Trials, Consolidated Standard of Reporting Trials 2010 Statement (CONSORT), CONSORT Extension for Non-Pharmacologic Treatment Interventions (CONSORT for NPT) and Good Clinical Practice, the detailed requirements for protocol writing, reporting, and practicing of clinical trial were classified and summarized in this article. By combining the practical situation of clinical trial of external treatment of TCM such as tuina, the requirernents for clinical trial protocol writing of external treatment of TCM were analyzed and acquired which could improve the quality of clinical trial protocol of external treatment of TCM, thus to provide references for standardized execution of TMC clinical trial and reports of research results.
Clinical Protocols ; standards ; Clinical Trials as Topic ; methods ; standards ; Humans ; Massage ; standards ; Quality Control ; Reference Standards

This paper is prepared to discuss the common issues in data management, such as building and training of data management team, standard operation procedure, document management, execution and communication, strategies to correct and prevent mistakes, and measures to improve the quality and efficiency of clinical trials and data management.
Clinical Trials as Topic ; Data Collection ; standards ; Information Storage and Retrieval ; standards

Quality and integrity of clinical trials and associated data management is a basis on the scientific and rightly assessments of drug safety and efficacy. While both normalization and standardization of clinical trial procedures assure quality of clinical trials and the relevant data processes, they will drive and improve the efficiency and reliability of real-world deliverables in clinical trials in turn. Currently, the comprehensive standards and practices of clinical trials and associated data management are globally established better, and US and EMA have enacted and implemented adequate guidances and regulations well. China is in the initial stage of development of relevant regulations regarding clinical trials and associated data management. This review will focus on the above-mentioned global regulations and standards of clinical data management in the views of good clinical data management standpoints, making references to improve the Chinese regulative system of clinical data management.
China ; Clinical Trials as Topic ; standards ; Data Collection ; standards ; Reproducibility of Results

This list of clincal data management documentation is to ensure standardized and adequate archival of trial documents and records in clinical data management, which is applicable to all of phase I-IV clinical trials.
Clinical Trials as Topic ; Data Collection ; standards ; Documentation ; standards

The STandards for Reporting Interventions in Clinical Trials Of Moxibustion (STRICTOM), in the form of a checklist and descriptions of checklist items, were designed to improve reporting of moxibustion trials, and thereby facilitating their interpretation and replication. The STRICTOM checklist included 7 items and 16 sub-items. These set out reporting guidelines for the moxibustion rationale, details of moxibustion, treatment regimen, other components of treatment, treatment provider background, control and comparator interventions, and precaution measures. In addition, there were descriptions of each item and examples of good reporting. It is intended that the STRICTOM can be used in conjunction with the main CONSORT Statement, extensions for nonpharmacologic treatment and pragmatic trials, and thereby raise the quality of reporting of clinical trials of moxibustion. Further comments will be solicited from the experts of the CONSORT Group, the STRICTA Group, acupuncture and moxibustion societies, and clinical trial authors for optimizing the STRICTOM.
Clinical Trials as Topic ; methods ; standards ; Humans ; Moxibustion ; methods ; standards ; Randomized Controlled Trials as Topic ; Research Design ; standards

Case report form (CRF) is a key document for data collection in clinical trials. A well-designed CRF is required for database construction, data accuracy, data query/cleaning, CRF completion and statistical analysis. A well-defined process or SOP should be in place for CRF design. Data collection should fully meet the demand of study protocol. The layout of CRF should be clear with well-structured fields and standard coding for fields.
Clinical Trials as Topic ; standards ; Data Collection ; standards ; Documentation ; standards ; Research Design ; standards